NDC 72678-034 Xurea

Urea

NDC Product Code 72678-034

NDC 72678-034-01

Package Description: 227 g in 1 JAR

NDC Product Information

Xurea with NDC 72678-034 is a a human prescription drug product labeled by National Bio Green Sciences Limited Liability Company. The generic name of Xurea is urea. The product's dosage form is cream and is administered via topical form.

Labeler Name: National Bio Green Sciences Limited Liability Company

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Xurea Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • UREA 390 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: National Bio Green Sciences Limited Liability Company
Labeler Code: 72678
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-19-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Xurea Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Xurea Description

Xurea Cream is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails.Each gram of Xurea Cream contains:ACTIVE: 39% Urea in a cream base of:INACTIVES: Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Propylene Glycol, Dimethicone, Melaleuca Alternifolia (Tea Tree) Oil, Helianthus Annuus (Sunflower) Oil, Chamomilla Recutita (Chamomile) Extract, Carbomer, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin.CHEMISTRYUrea is a diamide of carbonic acid with the following chemical structure:

Xurea - Clinical Pharmacology

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

Pharmacokinetics

The mechanism of action of topically applied Urea is not yet known.

Indications And Uses

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

Contraindications

Xurea Cream is contraindicated in patients with known hypersensitivity to any of the listed ingredients.

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin.

Precautions

Stop use and ask a doctor if redness or irritation develops. After applying this medication, wash hands and unaffected areas thoroughly. If swallowed, get medical help or contact Poison Control Center right away. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Pregnancy

Pregnancy Category BAnimal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Xurea Cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Xurea Cream is administered to a nursing woman.

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

Xurea - Dosage And Administration

Apply Xurea Cream to affected skin two to three times per day as needed or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue two to three times per day or as directed by a physician. Best applied to affected areas immediately after showering and just before bedtime.

How Is Xurea Supplied

Xurea (39% Urea Cream) is supplied in:8oz (227gm) Jar      NDC 72678-034-01Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). Protect from freezing. [See USP Controlled Room Temperature.]Manufactured for:NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANYBranchburg, NJ 08876Rx only

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